| CTRI Number |
CTRI/2018/06/014499 [Registered on: 11/06/2018] Trial Registered Prospectively |
| Last Modified On: |
08/06/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two different drugs for attenuation of the hemodynamic responses to laryngoscopy and endotracheal intubation |
|
Scientific Title of Study
|
Comparison of dexmedetomidine and clonidine for attenuation of the sympathoadrenal responses to laryngoscopy and endotracheal intubation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohit Gupta |
| Designation |
Post graduate student |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesiology and Intensive care, Ground floor,
Main OT building, Vardhman Mahavir Medical College and
Safdarjung Hospital, New Delhi 110029, India
South
DELHI
110029
India |
| Phone |
9999407977 |
| Fax |
|
| Email |
mohit.0802009@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pavan Nayar |
| Designation |
Consultant and Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesiology and Intensive care, Ground floor,
Main OT building, Vardhman Mahavir Medical College and
Safdarjung Hospital, New Delhi 110029, India
South
DELHI
110029
India |
| Phone |
9971935269 |
| Fax |
|
| Email |
pavannayar1957@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohit Gupta |
| Designation |
Post graduate student |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesiology and Intensive care, Ground floor,
Main OT building, Vardhman Mahavir Medical College and
Safdarjung Hospital, New Delhi 110029, India
South
DELHI
110029
India |
| Phone |
9999407977 |
| Fax |
|
| Email |
mohit.0802009@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung Hospital, Ring road, opposite aiims hospital, Ansari nagar west, Delhi |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesiology and Intensive care, Ground floor,
Main OT building, Vardhman Mahavir Medical College and
Safdarjung Hospital, New Delhi 110029, India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mohit Gupta |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Department of Anaesthesiology and Intensive care, O.T complex (1st/ 2nd / 3rd / 4th floor), Main OT building, near CIO
South
DELHI |
9999407977
mohit.0802009@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patient age 18-60 years of either sex, of ASA grades I and II having BMI less than or equal to 30 kg/m2, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group 1 (Isotonic saline) |
Patients will be given general anaesthesia. This would be followed by administration of inj. fentanyl citrate 1mcg/kg followed by infusion of 20 ml of isotonic saline over 10 minutes. Ramsay sedation score would be used to assess the level of sedation at 5 and 10 minutes during administration of study drug. After 10 minutes of test drug infusion, anaesthesia would be induced using inj. propofol 2mg/kg and inj. vecuronium bromide 0.12mg/kg. |
| Intervention |
GROUP 2 (Dexmedetomidine) |
Patients will be given general anaesthesia. This would be followed by administration of inj. fentanyl citrate 1mcg/kg followed by infusion of dexmedetomidine (1mcg/kg) over 10 minutes. Ramsay sedation score would be used to assess the level of sedation at 5 and 10 minutes during administration of study drug. After 10 minutes of test drug infusion, anaesthesia would be induced using inj. propofol 2mg/kg and inj. vecuronium bromide 0.12mg/kg. |
| Intervention |
GROUP 3 (Clonidine) |
Patients will be given general anaesthesia. This would be followed by administration of inj. fentanyl citrate 1mcg/kg followed by infusion of clonidine (1mcg/kg) over 10 minutes. Ramsay sedation score would be used to assess the level of sedation at 5 and 10 minutes during administration of study drug. After 10 minutes of test drug infusion, anaesthesia would be induced using inj. propofol 2mg/kg and inj. vecuronium bromide 0.12mg/kg. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grades I and II,
BMI less than or equal to 30 kg/m2 |
|
| ExclusionCriteria |
| Details |
1. Difficult airway (Mallampati grades 3 & 4 )
2. Pregnant and nursing women
3. Patients who require emergency surgical interventions.
4. Patients with hemodynamic instability or having cardiac, hepatic, renal, endocrine, hypertensive disorders and on medications like beta-blockers, digitalis, anti-psychotics, anxiolytics, sedatives or patients allergic to study medications. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the hemodynamic responses (HR, NIBP) and SpO2 variations in response to laryngoscopy and endotracheal intubation using either intravenous dexmedetomidine (1mcg/kg) or clonidine (1mcg/kg) |
At the time of pre-intubation and post-intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the level of sedation between the groups using Ramsay Sedation Score. |
After infusion of test drug |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
20/06/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
1. Prys– Roberts C, Greene LT , Meloche R , Foex P. Studies of anaesthesia in relation to hypertension. ii. Hemodynamic consequences of induction and endotracheal intubation. Br J Anaesth.1971;43:531-47.
2. Prys – Roberts C, Foex P , Biro GP , Roberts JG . Studies of anaesthesia in relation to hypertension. V. Adrenergic beta – receptor blockade. Br J Anaesth. 1973;45:671-81.
3. Kale SC, Mahajan RP, Jayalakshmi TS, Raghavan V, Das B. Nifedipine prevents the pressor response to laryngoscopy and tracheal intubation in patients with coronary artery disease. Anaesthesia.1988;43:495-7.
4. Mikawa k , Nishina k , Meckawa N , Obara H. Comparison of nicardipine, diltiazem and verapamil for controlling the cardiovascular responses to tracheal intubation. Br J Anaesth. 1996;76:221-6. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
1. To compare the hemodynamic responses (HR, NIBP) and SpO2 variations in response to laryngoscopy and endotracheal intubation using either intravenous dexmedetomidine (1mcg/kg) or clonidine (1mcg/kg) 2. To assess the level of sedation between the groups using Ramsay Sedation Score
HYPOTHESIS : Dexmedetomidine is better than clonidine, when administered as an infusion, prior to induction of general anaesthesia, in blunting the sympathoadrenal responses to both laryngoscopy and endotracheal intubation. |